Kornimate/medical-research-clean huggingface dataset:
comparative study of the consequence on innate immune response du to bacterial or viral infection in patients admitted to intensive care unit

Conditions: Viral Infection; Sepsis

Summary: patient admitted in intensive care unit (icu) for acute infection whether it be viral or bacterial had major impairment of the immune response. one hallmark of the immune impairment is presence of immature granulocyte (ig) in blood. depend of initial trigger (virus or bacteria) concentration, phenotype and function of ig seems to be different. in this prospective trial, immature granulocytes will be analyzed in depth in immunocompetent patients hospitalized in the intensive care unit for an acute viral or bacterial infection.

granulocytes are a key actor of immune response during acute viral or bacterial infection. during their maturation in bone marrow they went from immature form to mature form. in physiological condition only mature form are present in blood. however, in case of acute viral or bacterial infection, immature granulocytes (cd10low/cd16low) could be released in blood. but concentration, phenotype and function of these ig seems to be different between bacterial and viral infection. indeed, in bacterial infection, concentration of ig is high (\> 20%) and they expressed cd64 and cd123. in case of viral infection, blood concentration of ig is lower and they expressed cd62-l. these phenotype differences are probably associated with functional modification. a more precise characterization of the phenotype and functions of ig according to the stimulus (bacterial or viral) could provide a better understanding of the innate immune response in patients hospitalized in icu for acute infection. the investigators will analysis by flow cytometry ig subsets (pdl1 cd62l lox-1 cd45 cd64 cd15 cd123 cd16 cd10 crth2) of adult immunocompetent patient hospitalized in icu for less than 24 hours for acute infection. transcriptomic and cytokine analysis will be also performed. infectious status will be validated by a blind adjudication committee which will classify patient in certain bacterial infection, certain viral infection, co-infection and no confirmed infection.

Eligibility criteria:
inclusion criteria: * bacterial infection: * adult patient hospitalized for less than 24 hours in icu for community documented sepsis * vasopressor support * sofa score \> 4 * viral infection: * adult patient hospitalized for less than 24 hours in icu for confirmed viral acute infection. * high flow oxygen, non-invasive or invasive ventilation since less than 24 hours * moderate to severe ards with pao2/fio2 \< 200mmhg and a fio2 ≥ 0.6. exclusion criteria: * bacterial infection: * antibiotics or hospitalized in icu in the previous 3 months * immunocompromized patient * ongoing acute or chronic viral infection * viral infection: * antibiotics or hospitalized in icu in the previous 3 months * immunocompromized patient * current antibiotics * ongoing chronic viral infection.

Keywords: bacteria virus immune response acute infection immature granulocyte
the effect of berry extract administration on cognitive health

Conditions: Cognitive Impairment; Overweight and Obesity

Summary: the purpose of this study is to investigate the effects of daily supplementation of brainport for a period of 6 months on cognitive health.


Eligibility criteria:
inclusion criteria: * healthy individuals * age between 40 and 60 years * bmi 25 - 35 kg/m2 exclusion criteria: * history of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, heent (head, ears, eyes, nose, throat). dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol. * diabetes * use of medication that might have influence on endpoints (hypertension medication) * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study * use of antibiotics in the 30 days prior to the start of the study * use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine * pregnancy, lactation * abuse of products (\> 20 alcoholic consumptions per week and drugs) * smoking * weight gain or loss (\> 3 kg in previous 3 months) * high physical activity (\>4.5 hours of running/week) * history of any side effects towards intake of berries
study of different doses of folic acid in combination with methotrexate in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: introduction: methotrexate is the sheet anchor for the treatment of rheumatoid arthritis. folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate adverse effects. patients at our center are usually on the higher dose. however, it is unclear if higher doses are required, recent international recommendations suggest 5-10 mg per week only. objectives: to randomize rheumatoid patients being being started on methotrexate into 2 groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice a week (10 mg per week) for 24weeks. to look at difference in 1. adverse effects due to methotrexate a. minor adverse effects: by symptom chart a. major adverse effects: cytopenia (predefined) and transaminitis. 2. disease activity using disease activity score 28 joints (3 variable) and functional status by health assessment questionnaire 3. rbc folic acid levels methodology: randomised controlled trial, double blinded, placebo controlled. sample size 50 in each group. one group of patients will receive folic acid 5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5 mg 6 days a week for 24 weeks. patients will be administered adverse effects proforma, assessed for having cytopenias and transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in the beginning at then at 8,16 and 24 weeks. in addition will look at the functional status and rbc folate levels at 0 and 24 weeks. statistical analysis using chi-square test for proportions and t test for continuous variables.

this trial will include new rheumatoid arthritis patients these patients will then be randomized into two groups - one which continues to take the same folic acid dose and one which is shifted to folic acid 10 mg per week.

Eligibility criteria:
inclusion criteria: * age 18-75 years * patients fulfilling the 1987 american college of rheumatology rheumatoid arthritis criteria exclusion criteria: * hb less than 8 g per dl or tlc less than 3500 or platelet less than 1 lac or sgot or sgpt more than 60 u/l * serious concomitant medical illnesses such as cancer, liver or renal disease

Keywords: rheumatoid arthritis folic acid methotrexate
contextualized neuropsychological rehabilitation for cns cancer survivors: the impact program

Conditions: Brain Cancer; Cognitive Impairment

Summary: the aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain cancer survivors, and the relatively few studied interventions have proven limited effects. arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of carers that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions. the "i'm aware: patients and carers together (impact)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. the present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.

Eligibility criteria:
inclusion criteria: * diagnosis of brain cancer * completed primary treatment at least 6 months ago * medically stable * speaks and understand danish * living with a carer aged 18 or over, who also speaks and understands danish and consents to participate in the study alongside the patient exclusion criteria: • confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment

Keywords: brain cancer brain tumor cognitive impairment neurobehavioral impairment neuropsychological rehabilitation
long-term effects of transcranial direct current stimulation (tdcs) on patients with phantom limb pain (plp)

Conditions: Phantom Limb Pain

Summary: * phantom limb pain (plp) refers to pain in a limb that has been amputated or deafferented. phantom limb pain might be related to brain cortical plastic changes. * the purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tdcs) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain. this is a crossover sham control.


Eligibility criteria:
inclusion criteria: * age 18 to 80 * limb amputation from at least 6 months before study enrollment * presence of plp at least 2 times a week and present 4 weeks prior to onset of study * written informed consent exclusion criteria: * coexistence of major neurological or psychiatric diseases * being actively enrolled in a separate study targeting pain relief * post traumatic stress disorder (ptsd) diagnosed patients * any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure * pregnant women * within the traumatic amputees group - subjects diagnosed with diabetes

Keywords: phantom limb pain transcranial direct current stimulation amputation diabetes mellitus
alexithymia in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the study included 55 patients having ankylosing spondylitis (as) for at least 1 year diagnosed according to the asas classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. demographic data were recorded for 55 as patients who were subsequently assessed using the basmi (bath ankylosing spondylitis metrology index) in terms of elasticity and spinal mobility as well as the basfi (bath ankylosing spondylitis functional index) to determine functional status, the basdai (bath ankylosing spondylitis disease activity index) to assess the disease activity and the asqol (ankylosing spondylitis quality of life questionnaire) to evaluate quality of life. the toronto alexithymia scale-20 (tas-20) was used for assessment of alexithymia and beck's depression inventory (bdi) for depression among patients.

the study included 55 patients having ankylosing spondylitis (as) for at least 1 year diagnosed according to the asas classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. demographic data were recorded for 55 as patients who were subsequently assessed using the basmi (bath ankylosing spondylitis metrology index) in terms of elasticity and spinal mobility as well as the basfi (bath ankylosing spondylitis functional index) to determine functional status, the basdai (bath ankylosing spondylitis disease activity index) to assess the disease activity and the asqol (ankylosing spondylitis quality of life questionnaire) to evaluate quality of life. the toronto alexithymia scale-20 (tas-20) was used for assessment of alexithymia and beck's depression inventory (bdi) for depression among patients.

Eligibility criteria:
inclusion criteria: * diagnosed as as for at least 1 year according to the asas classification criteria * over 18 years old exclusion criteria: * fibromyalgia * age less than 18 years * vision and hearing impairment * neurological disease (parkinson's disease, multiple sclerosis, cerebrovascular disease), * history of a psychiatric disorder (schizophrenia, bipolar disorder) * history of chronic condition (dm, thyroid disease) or malignancy

Keywords: ankylosing spondylitis alexithymia
clinical evaluation of the progensa(registered trademark) prostate cancer gene 3 (pca3) assay in men with a previous negative biopsy result

Conditions: Prostatic Neoplasms

Summary: the objective of this multi-center clinical study is to determine the association of the pca3 score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. an elevated pca3 score is thought to be associated with an increased likelihood of positive biopsy. the results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.

pca3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. studies have shown that because pca3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (psa) testing. gen-probe's progensa(r) pca3 assay is the first urine-based molecular diagnostic assay for prostate cancer.

Eligibility criteria:
inclusion criteria: * men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician. * the subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents exclusion criteria: * use of medications or hormones that are known to affect serum psa levels within 3 - 6 months of study enrollment * clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment * history of prostate cancer * history of invasive treatments for benign prostatic hypertrophy (bph) or lower urinary tract symptoms within 6 months of study enrollment * medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject * participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. exception: trials for non-prostate conditions may be acceptable, with approval by the investigator and sponsor

Keywords: prostate cancer prostate biopsy pca3
low calorie diet or vlckd combined with physical training for preserving muscle mass during weight loss in sarcopenic obesity

Conditions: Sarcopenic Obesity

Summary: the prevalence of sarcopenic obesity (so) is increasing worldwide, posing important challenges to public health and national health care system, especially during the covid pandemic. in subjects with so, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. lifestyle modification with adequate nutrition and proper physical activity is essential to counteract so progression. in accordance with the position statement of the italian society of endocrinology, very low calorie ketogenic diet (vlckd), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of so. moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases. to date, the effects of physical training during vlckd have not been studied. the aim is to determine the efficacy of vlckd combined with interval training, compared to a vlckd or a lcd alone, on weight-loss, body composition and physical performance in patient with so.


Eligibility criteria:
inclusion criteria: * obesity (bmi 30-40) * fat mass % ( \> 41% for w, \>29% for m) * homa-ir \> 2,5 exclusion criteria: * known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery
tidal volume in patients with "de novo" acute hypoxemic respiratory failure

Conditions: Acute Hypoxemic Respiratory Failure

Summary: protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).recent data suggest patient self-inflicted lung injury (p-sili) as a possible mechanism aggravating lung damage in these patients. the aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.


Eligibility criteria:
inclusion criteria: * acute respiratory failure (arf) ( 100 \<pao2/fio2 \<300) due to covid-19 infection * informed consent * enrollment within the first 24 hours after arf exclusion criteria: * clinical, radiological or istological evidence of chronic pulmonary disease. * body mass index (bmi) \> 30 kg/m2; * previous diagnosis of obstructive sleep apnea syndrome (osas) * chest wall disease * heart failure * severe hemodynamic instability ( need for amine support) * acute coronary syndrome (acs) * severe arrhythmia * patients unable to protect respiratory airways * respiratory arrest and need for endotracheal intubation * pregnancy * need for sedation * home long-term oxygen therapy

Keywords: de novo arf
loratadine for the reduction of g-csf induced bone pain in patients with multiple myeloma undergoing stem cell mobilization

Conditions: Plasma Cell Myeloma

Summary: this early phase i trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (g-csf) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.

primary objective: i. to evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., neupogen, zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients. secondary objectives: i. to examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain. ii. to identify risk factors associated with developing filgrastim induced bone pain. outline: patients are randomized to 1 of 2 cohorts. cohort i: beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine orally (po) once daily (qd). treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity. cohort ii: beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo po qd. treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * patient must be able to provide informed consent * patients with confirmed diagnosis of multiple myeloma * able to swallow and retain oral medication * all ethnic groups are eligible exclusion criteria: * non-english speaking person * patients undergoing haploidentical allogeneic hematopoietic stem cell transplant * known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds * any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study * on therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study
clinical study for the bongo nasal expiratory positive airway pressure (epap) device in the treatment of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: single center clinical study for the bongo nasal epap device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data


Eligibility criteria:
inclusion criteria: * capacity and willingness to sign informed consent * ≥ 21 years of age * diagnosis of mild to moderate osa (ahi ≥ 5 and ahi \< 30) within 12 months of the screening visit. * able to tolerate using the device during a day time trial/acclimation * are currently using cpap or have been prescribed cpap and are considered cpap non-adherent (as per either their cpap data card and/or verbal confirmation of a diagnosis and unwillingness to use cpap) exclusion criteria: * nasal deformities * severe nasal allergies * rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum * co-morbid sleep disorders * currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated) * uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure. * full face mask user * mouth breather * pregnant (female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)